MFG Compliance Specialist Manufacturing Fremont , CA, US Pay Rate Low: 45.00 | Pay Rate High: 49.00 + Added - 05/11/2024 Apply for Job _Our client is a global, research-driven pharmaceutical focusing on treatment options for diseases and conditions for which there is no satisfactory treatment option to date. The company is looking for an_ **_MFG Compliance Specialist_** _to join the team. This is an amazing opportunity to work on cutting edge treatments and make a difference!_ **Location:** Fremont, CA **Pay:** $45/ hr. - $49/ hr. **Job Type:** 6-month contract **Job Summary:** The Change Control and Continuous Improvement Specialist will play a pivotal role in managing and coordinating change control records and projects supporting manufacturing operations in a biopharmaceutical setting. The specialist will be responsible for overseeing the change control process, CAPAs (Corrective and Preventive Actions), SOP revisions, and periodic reviews. Additionally, this role will involve leading improvement projects, identifying areas for process optimization, and applying operational excellence tools to enhance efficiency and reduce variability in manufacturing operations. **Key Responsibilities:** + Manage change control records, ensuring adherence to cGMP guidelines and applicable regional regulations + Support the monitoring and reporting of deviations, ensuring proper documentation and resolution in line with cGMP and company standards + Identify areas for process improvement and apply operational excellence tools to reduce variability and enhance efficiency across manufacturing processes + Oversee and track Corrective and Preventive Actions to drive improvements and prevent recurring issues + Lead and manage cross-functional projects, ensuring that scope, timelines, and deliverables are met. Work closely with team members to ensure effective communication and project completion + Manage the revision and approval process for Standard Operating Procedures (SOPs), ensuring they align with regulatory requirements and best practices + Oversee periodic reviews to ensure that processes and documents remain compliant and effective over time + Assist with audit preparation and respond to findings related to change control, CAPAs, deviations, and SOPs **Qualifications** + Bachelor’s degree in a related field (e.g., Biopharmaceuticals or Life Sciences) + 2+ years of experience in biopharmaceutical manufacturing or a related industry + Hands-on experience in cGMP environments, including knowledge of regulations from various regional jurisdictions + Experience in managing change controls, deviations, CAPAs, and SOP revisions + Familiarity with audits and inspections in the pharmaceutical manufacturing space + Ability to write clear and concise technical documents, including SOPs, protocols, deviation reports, etc. + Strong understanding of cGMP systems and regulatory compliance + Proficient in project management, with a proven ability to manage cross-functional projects + Experience in a manufacturing operator or technician role is a plus + Familiarity with process improvement methodologies (e.g., Lean, Six Sigma) is beneficial INDBH \#LI-DNP We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.